Thursday, 18 Jul 2019

You are here

More Trouble for Mallinckrodt’s Acthar Gel

Reuters has reported that Mallinckrodt Plc has tentatively agreed to pay $15.4 million to resolve a US Justice Department investigation into company promotional practices for Acthar gel.

The company came under scrutiny when it was published that Medicare was paying $16,2371 per patient for nearly 3100 patients, thereby becoming one of Medicare’s highest paid expenditures at a half-billion US dollars per year.

In March, the department joined a pair of whistleblower lawsuits that alleged Questcor Pharmaceuticals, which Mallinckrodt acquired in 2014, defrauded government healthcare programs by illegally marketing Acthar.

The Justice department has been investigating Mallinckrodt, alleging misuse of patient assistance charity as a conduit to improperly subsidize Medicare patients’ copayment obligations. This occuring while Mallinckrodt notoriously raised drug prices for Acthar Gel from $40 a vial in 2001 to nearly $40,000 per vial today.  

Drug companies are prohibited from subsidizing copayments for patients enrolled in the government’s Medicare healthcare program for those aged 65 and older. Companies may donate to non-profits providing copay assistance as long as they are independent.

The company has said that this agreement-in-principle to resolve the department’s marketing investigation is subject to finalization and contains no admission of wrongdoing.

In 2018 Acthar sales were $1.11 billion in 2018, or 35% of Mallinckrodt’s total revenue $3.2 billion in net sales.

(read the attached link for the full story) 

The case is U.S. ex rel Strunck v. Mallinckrodt ARD LLC, U.S. District Court, Eastern District of Pennsylvania, No. 12-cv-175.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Rituximab Superior to Cyclosporine for Membranous Nephropathy

The NEJM has reported that rituximab (RTX) and cyclosporine (CYA) was noninferior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months and was superior in maintaining proteinuria remission up to 24 months. 

Management of Hemophagocytic Lymphohistiocytosis (HLH) in Adults

Hemophagocytic lymphohistiocytosis (HLH) is a severe hyperinflammatory syndrome induced by activated macrophages and cytotoxic T cells.  HLH manifests recurrent fever, cytopenia, liver dysfunction, and a sepsis-like syndrome that may complicated by multiple organ failure.

FDA Public Review of CBD Oil

The US Food and Drug Administration convened a public hearing and specialty panel on May 31st to review the potential use, safety and effectiveness of cannabidiol (CBD) products that do not contain THC.

In his opening remarks, the FDA acting Commissioner Dr. Ned Sharpless said, "critical questions remain about the safety" of CBD products, especially since the growth of the CBD market has exploded in the past year.

Steroids, Not Biologics, Drive Arthroplasty Infections in RA

Medicare and Truven MarketScan administrative data study (2006 through 2015) of rheumatoid arthritis (RA) undergoing arthroplasty found that while that the risks of perioperative infection was similar across biologics, the infection risk with glucocorticoid use, especially at > 10 mg/d, was significantly greater.

Generic Price Fixing Alleged by State Prosecutors

The NY Times and 60 Minutes have reported that Connecticut, along with 43 other states, filed a mega-lawsuit accusing the generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. (Citation source: https://buff.ly/2vSmv03)